Five things physicians don’t know about biosimilars
While there are many physicians who are very knowledgeable about biosimilars, a large number of them will require education about basic biosimilars concepts, according to the results of a new survey.
The survey showed that more than three-quarters (76.8%) of physicians had heard the term biosimilars in the month prior to the survey.
Some of those concept gaps include assistance in understanding what is a biologic or a biosimilar drug, according to the Biosimilars Forum physician survey, published in Advances in Therapy, and presented recently at the Drug Information Association (DIA) Biosimilars 2016 conference in Washington, D.C.
“In order to maximize the potential of biosimilars for increased patient access and potential cost savings, physicians must be knowledgeable about biosimilars so that they in turn will be comfortable prescribing biosimilars to their patients,” Hillel Cohen, co-chair of the education committee, Biosimilars Forum.
The questions were developed in a collaborative effort of scientists, physicians and communication specialists from the different companies of the Biosimilars Forum. Responses were obtained from 1,201 physicians who specialized in six therapeutic areas for which biosimilars are in development (200 per specialty).
Most physicians surveyed do not clearly understand the concept of extrapolation as applied to biosimilars with only 12% of survey respondents stating that they trust extrapolation of the studied biosimilar indication(s) as the basis to obtain approval of other licensed indications of the originator product, according to the survey. Almost 60% of respondents correctly understood that to be approved as “interchangeable,” a biosimilar must be shown to be safe and effective for back-and-forth switching with no negative impacts to safety or efficacy, but almost 80% did not agree, or potentially did not realize, that an FDA designation of interchangeable may enable a pharmacist to switch between the originator biologic and biosimilar, and vice versa.
A little more than half of physicians surveyed know that in order to be approved, FDA must find a biosimilar to be equally effective (62.3%) and safe (57.2%) when compared to the originator biologic. Fewer than half of the respondents (44.8%) believe that biosimilars will be safe and appropriate for use in existing patients as well as naïve patients.
Most physicians trust in and have high regard for the FDA with nearly three-quarters of survey respondents saying that they trust the FDA’s biosimilar approval decisions.
Overall, the physicians surveyed expressed a general agreement that switching an existing patient to a biosimilar may be appropriate, with nine in 10 saying they would consider switching a patient from an originator biologic to a biosimilar, as an effective alternative to the originator, if it would help the patient have better access to his/her medications. In addition, 82.2% believe biosimilars will expand treatment options and provide savings to patients and the healthcare system.
“The findings should be used to help guide the content of programs to educate physicians and other stakeholders,” Cohen says. “The educational programs should be delivered by trusted groups or individuals. The Biosimilars Forum is willing and ready to provide unbiased and comprehensive support in this effort.”
The results also highlight the challenge in helping physicians understand and appreciate that the biosimilar drug development paradigm differs in several important ways from the development of both originator drugs and generic drugs, according to Cohen.
The survey identified five knowledge gaps with current biologics prescribers that are:
1. Defining biologics, biosimilars and biosimilarity.
2. Understanding the approval process and the FDA’s use of totality of evidence to evaluate biosimilars.
3. Appreciation that the safety profile of a biosimilar is expected to be the same as that of the originator biologic.
4. Understanding how decisions are made by the FDA for extrapolation of indications.
5. Defining interchangeability and the related rules regarding pharmacy-level substitution.